The present invention relates generally to fluid processing systems and apparatus, and more particularly to a disposable fluid processing system incorporating an integral distribution manifold which provides for more economical construction and more convenient installation, and an apparatus for use therewith.
Various methods and apparatus have been developed which utilize disposable single-use processing systems formed of plastics such as vinyl for accomplishing fluid processing procedures. In the medical field, for example, processing systems have been developed for blood fractionation procedures, such as plasmapheresis, leukopheresis and plateletpheresis, wherein whole blood is separated into one or more fractions by means of either a filter element or by means of centrifugration, and for hemodialysis procedures, wherein diffusion exchange occurs through a membrane between whole blood and a dialysis solution.
Typically, such disposable processing systems are relatively complex in construction, requiring a plurality of Y-type and T-type connections and associated solvent bonds to establish necessary fluid flow paths between the system components. This complexity not only adds to the cost of manufacture, but also works to the detriment of system reliablity. Accordingly, it is desirable in disposable fluid processing systems that the number of connections be minimized to the extent possible. The present invention is directed to a flow system and actuator apparatus for use therewith wherein the majority of fluid connections are made along a single seal line forming part of a common fluid flow control and distribution manifold.
It is also desirable, to further reduce manufacturing cost, that a single flow system construction have the capability of performing multiple fluid processing procedures. In particular, in blood processing applications it is desirable that a single system construction serve for both batch flow procedures, wherein an aliquot of blood is first drawn from a donor and processed during a recurring draw cycle, and is then returned to the donor during recurrent intervening return cycles; and for continuous flow procedures, wherein blood is continuously drawn, processed, and returned, using either two separate phlebotomy needles or a single dual lumen needle. This permits larger quantities of a single flow system construction to be manufactured, with attendant reductions in material and labor costs. The present invention is directed to a flow system and apparatus which accommodates these procedures without modification, thereby realizing the benefits of higher volume production.
Furthermore, the processor apparatus with which disposable processing systems are used typically include multiple pump, detector and valving elements on which particular components and tubing segments of the fluid circuit must be individually installed. Consequently, the set-up procedure may be undesirably complex so as to require a specially trained operator, and may require an undesirably long time period to complete. Even with the use of a specially trained operator, the potential remains for error, as where the wrong tubing segment is installed on a particular element of the apparatus.
Accordingly, it is desirable that the procedure for installing a flow system in an apparatus be as simple as possible, preferably establishing operative connections to critical valving and other elements of the apparatus with insertion of a single system component, and with minimal opportunity for error. The present invention is directed to a disposable flow system and apparatus wherein the system includes a fluid distribution manifold which is received as a unit in the apparatus to establish with one insertion step operative connection with a plurality of valving elements.
Accordingly, one of the principal objects of the present invention is to provide a new and improved fluid processing system for performing a fluid fractionation procedure, such as hemodialysis or plasmapheresis.
It is another principal object of the present invention to provide a fluid processing system and apparatus which accommodates a number of different fluid fractionation procedures without modification.
It is another principal object of the present invention to provide a fluid processing system and apparatus which is easier to set-up and which provides reduced possibility for operator error.
It is another principal object of the present invention to provide a disposable fluid flow system for use in conjunction with fluid separator or processing apparatus which is more economical to manufacture.